|
PFIZER CONSUMER HEALTH CARE THERMACARE HEATWRAPS MULTI-PURPOSE MUSCLE PAIN; DISPOSABLE PACK, HOT
|
Back to Search Results |
|
| Lot Number S68516 |
| Device Problems
Leak/Splash (1354); Nonstandard Device (1420); Material Rupture (1546); Material Separation (1562)
|
| Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
|
Event Type
malfunction
|
|
Event Description
|
|
Event verbatim [preferred term] one of the heat pockets ruptured and she had black powder running down her leg [device leakage], uses for menstrual cramps [intentional device use issue].This is a spontaneous report from a contactable pharmacist reported for herself.A (b)(6) years-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number s68516 , expiration date jul2020, from an unspecified date and ongoing at applied to skin one or 2 days a month for menstrual cramps.Medical history was none.There were no concomitant medications.The patient purchased thermacare advanced heat muscle pain therapy multipurpose wraps.She used them for menstrual cramps because they stuck on the sides.She stuck the wrap to her underwear.When she went to the bathroom, one of the heat pockets had ruptured and she had black powder running down her leg on (b)(6) 2019.The heat cells came away from adhesive and had separated.Packaging was sealed and intact.She wasn't pulling it off.She had been using the product since it first came out.She stated she felt the product was defective.She felt like the brand name worked better than the off label.One that she bought before felt more like a hand warmer, where the sand fell to the bottom.The thermacare brand had the cells.After having one bad experience, she had only bought the thermacare brand.She thinks it was probably the (pharmacy name) brand that she had bought since that was where she worked.She no longer had to provide upc, lot or expiry.Packaging was not sealed and intact.Device was not available for evaluation.The pharmacist assessed both events not serious.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event uses for menstrual cramps was not resolved and the outcome of the other event was unknown.Additional information has been requested and will be provided as it becomes available.Company clinical evaluation comment: the device malfunction has not yet been confirmed.The patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.Comment: the device malfunction has not yet been confirmed.The patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.
|
| |
|
Manufacturer Narrative
|
|
Investigation summary: the root cause category is non assignable (complaint not confirmed).The sample is not available from consumer for evaluation, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This complaint was not confirmed as a cell damaged/leaking occurrence.If confirmed the complaint could be a malfunction with the heat wrap and potentially cause a skin burn.The severity level is s3 per rpt-74091 ¿bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, effective date: 28sep2018.Safety is notified of s3, s4 and s5 per sop-58303 ¿processing consumer complaints¿, section 7.4, version 10.0, effective date: 15nov2018.Date of capa implementation:process related? no complaint confirmed?: no.Design related: no notify safety: no.
|
| |
|
Event Description
|
|
One of the heat pockets ruptured and she had black powder running down her leg [device leakage], uses for menstrual cramps [intentional device use issue].Case narrative: this is a spontaneous report from a contactable pharmacist reported for herself.A 37-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number: s68516, expiration date: jul2020, date of manufacture: 27aug2017, from an unspecified date and ongoing at applied to skin one or 2 days a month for menstrual cramps.Medical history was none.There were no concomitant medications.The patient purchased thermacare advanced heat muscle pain therapy multipurpose wraps.She used them for menstrual cramps because they stuck on the sides.She stuck the wrap to her underwear.When she went to the bathroom, one of the heat pockets had ruptured and she had black powder running down her leg on (b)(6) 2019.The heat cells came away from adhesive and had separated.Packaging was sealed and intact.She wasn't pulling it off.She had been using the product since it first came out.She stated she felt the product was defective.She felt like the brand name worked better than the off label.One that she bought before felt more like a hand warmer, where the sand fell to the bottom.The thermacare brand had the cells.After having one bad experience, she had only bought the thermacare brand.She thinks it was probably the (pharmacy name) brand that she had bought since that was where she worked.She no longer had to provide upc, lot or expiry.Packaging was not sealed and intact.Device was not available for evaluation.The pharmacist assessed both events not serious.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event uses for menstrual cramps was not resolved and the outcome of the other event was unknown.According to the product quality complaint group: investigation summary: the root cause category is non assignable (complaint not confirmed).The sample is not available from consumer for evaluation, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation (b)(4) t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).This complaint was not confirmed as a cell damaged/leaking occurrence.If confirmed the complaint could be a malfunction with the heat wrap and potentially cause a skin burn.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, effective date: 28sep2018.Safety is notified of s3, s4 and s5 per sop-58303 "processing consumer complaints", section 7.4, version 10.0, effective date: 15nov2018.Date of capa implementation:process related? no complaint confirmed?: no.Design related: no notify safety: no.Follow-up (18feb2019): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available., comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.
|
| |
|
Manufacturer Narrative
|
|
According to the product quality complaint group for "subclass: cells damaged/leaking": batch: s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside (4 wraps total).There was only one retain required for the batch.Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 a previous related complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.One previous complaint (#) was confirmed to have a manufacturing related root cause for the cells damaged/leaking.The root cause was identified as equipment, other.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14feb2017 through 14feb2019/ manufacturing site: pfizer albany/ complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 17 complaints for muscle and joint (m&j) products during this time period for the class/subclass.Of the 17 complaints five complaint have the batch number recorded as unknown.The 12 remaining complaints were evaluated.Two complaints were confirmed to have a manufacturing related root cause for the cells damaged/leaking.Pr- 2156466 (#) identified the root cause as equipment/other; brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Pr- 2222400 (#) determined the root cause as equipment - mechanical failure caused by chemistry.
|
| |
|
Event Description
|
|
One of the heat pockets ruptured and she had black powder running down her leg [device leakage], uses for menstrual cramps [intentional device use issue].Case narrative: this is a spontaneous report from a contactable pharmacist reported for herself.A 37-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number: s68516, expiration date: jul2020, date of manufacture: 27aug2017, from an unspecified date and ongoing at applied to skin one or 2 days a month for menstrual cramps.Medical history was none.There were no concomitant medications.The patient purchased thermacare advanced heat muscle pain therapy multipurpose wraps.She used them for menstrual cramps because they stuck on the sides.She stuck the wrap to her underwear.When she went to the bathroom, one of the heat pockets had ruptured and she had black powder running down her leg on (b)(6) 2019.The heat cells came away from adhesive and had separated.Packaging was sealed and intact.She wasn't pulling it off.She had been using the product since it first came out.She stated she felt the product was defective.She felt like the brand name worked better than the off label.One that she bought before felt more like a hand warmer, where the sand fell to the bottom.The thermacare brand had the cells.After having one bad experience, she had only bought the thermacare brand.She thinks it was probably the (pharmacy name) brand that she had bought since that was where she worked.She no longer had to provide upc, lot or expiry.Packaging was not sealed and intact.Device was not available for evaluation.The pharmacist assessed both events not serious.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event uses for menstrual cramps was not resolved and the outcome of the other event was unknown.According to the product quality complaint group for "subclass: cells damaged/leaking": batch: s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside (4 wraps total).There was only one retain required for the batch.Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 a previous related complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.One previous complaint (#) was confirmed to have a manufacturing related root cause for the cells damaged/leaking.The root cause was identified as equipment, other.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14feb2017 through 14feb2019/ manufacturing site: pfizer albany/ complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 17 complaints for muscle and joint (m&j) products during this time period for the class/subclass.Of the 17 complaints five complaint have the batch number recorded as unknown.The 12 remaining complaints were evaluated.Two complaints were confirmed to have a manufacturing related root cause for the cells damaged/leaking.Pr- 2156466 (#) identified the root cause as equipment/other; brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Pr- 2222400 (#) determined the root cause as equipment - mechanical failure caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.Based on the pcom search for the subclass of cells damaged/leaking for m&j products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cells damaged leaking for m&j products, refer to attachment 1 trend graph #.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).The sample is not available from consumer for evaluation, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.This complaint was not confirmed as a cell damaged/leaking occurrence.If confirmed the complaint could be a malfunction with the heat wrap and potentially cause a skin burn.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, effective date: 28sep2018.Safety is notified of s3, s4 and s5 per sop-58303 "processing consumer complaints", section 7.4, version 10.0, effective date: 15nov2018.Date of capa implementation:process related? no complaint confirmed?: no.Design related: no notify safety: no.Additional information received from product quality complaint group for subclass: adverse event safety request for investigation included: quality impact: no.The thermal data was reviewed and there were no thermal results outside the required specifications per muscle and joint formula card spec-22096, effective date: 28nov2016.Prelim.Confirmation status: not confirmed.Further investigation req'd?: no.Investigation summary: the root cause category is non assignable (complaint not confirmed as a quality defect).Consumer reports "black powder running down leg." the sample is not available from consumer for evaluation, the complaint cannot be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr -2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the sub-class of cells damaged/leaking.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr-2379610.Process related?: no.Complaint confirmed?: no.Design related?: no.Notify safety? no.Follow-up (18feb2019): new information received from the product quality complaint group included investigational results.Follow-up (22feb2019): new information received from the product quality complaint group included investigational results.Follow-up (14mar2019): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.The above referenced lot number: s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.The above referenced lot number: s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Manufacturer Narrative
|
|
Batch: s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside (4 wraps total).There was only one retain required for the batch.Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 a previous related complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.One previous complaint (#) was confirmed to have a manufacturing related root cause for the cells damaged/leaking.The root cause was identified as equipment, other.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14feb2017 through 14feb2019/ manufacturing site: pfizer albany/ complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 17 complaints for muscle and joint (m&j) products during this time period for the class/subclass.Of the 17 complaints five complaint have the batch number recorded as unknown.The 12 remaining complaints were evaluated.Two complaints were confirmed to have a manufacturing related root cause for the cells damaged/leaking.Pr- 2156466 (#) identified the root cause as equipment/other; brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Pr- 2222400 (#) determined the root cause as equipment - mechanical failure caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper s.
|
| |
|
Event Description
|
|
One of the heat pockets ruptured and she had black powder running down her leg [device leakage], uses for menstrual cramps [intentional device use issue].Case narrative: this is a spontaneous report from a contactable pharmacist reported for herself.A 37-year-old female patient started to receive thermacare heatwrap (thermacare heatwraps multi-purpose muscle pain), device lot number: s68516, expiration date: jul2020, date of manufacture: 27aug2017, from an unspecified date and ongoing at applied to skin one or 2 days a month for menstrual cramps.Medical history was none.There were no concomitant medications.The patient purchased thermacare advanced heat muscle pain therapy multipurpose wraps.She used them for menstrual cramps because they stuck on the sides.She stuck the wrap to her underwear.When she went to the bathroom, one of the heat pockets had ruptured and she had black powder running down her leg on (b)(6) 2019.The heat cells came away from adhesive and had separated.Packaging was sealed and intact.She wasn't pulling it off.She had been using the product since it first came out.She stated she felt the product was defective.She felt like the brand name worked better than the off label.One that she bought before felt more like a hand warmer, where the sand fell to the bottom.The thermacare brand had the cells.After having one bad experience, she had only bought the thermacare brand.She thinks it was probably the (pharmacy name) brand that she had bought since that was where she worked.She no longer had to provide upc, lot or expiry.Packaging was not sealed and intact.Device was not available for evaluation.The pharmacist assessed both events not serious.The action taken in response to the events for thermacare heatwrap was dose not changed.The outcome of the event uses for menstrual cramps was not resolved and the outcome of the other event was unknown.According to the product quality complaint group: batch: s68516 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included one carton, and the four pouched wraps inside (4 wraps total).There was only one retain required for the batch.Inspection shows no obvious defects to the cartons or pouches.All wraps have cell packs with good seals, with no damage or leaking.Retain inspection was completed on 27mar2018 a previous related complaint.An evaluation of the complaint history confirms that this is the fourth complaint for the sub class cells damaged/leaking received at the albany site requiring an evaluation for this batch.One previous complaint (#) was confirmed to have a manufacturing related root cause for the cells damaged/leaking.The root cause was identified as equipment, other.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14feb2017 through 14feb2019/ manufacturing site: pfizer albany/ complaint class: wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 17 complaints for muscle and joint (m&j) products during this time period for the class/subclass.Of the 17 complaints five complaint have the batch number recorded as unknown.The 12 remaining complaints were evaluated.Two complaints were confirmed to have a manufacturing related root cause for the cells damaged/leaking.Pr- 2156466 (#) identified the root cause as equipment/other; brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.Pr- 2222400 (#) determined the root cause as equipment - mechanical failure caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.Based on the pcom search for the subclass of cells damaged/leaking for m&j products the data did not show an increase over time (24 months).There is not a trend identified for the subclass cells damaged leaking for m&j products, refer to attachment 1 trend graph #.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch at the time of release.Investigation summary: the root cause category is non assignable (complaint not confirmed).The sample is not available from consumer for evaluation, the complaint can not be confirmed.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation pr 2379610 t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the same subclass.This batch: s68516 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation pr 2379610.This complaint was not confirmed as a cell damaged/leaking occurrence.If confirmed the complaint could be a malfunction with the heat wrap and potentially cause a skin burn.The severity level is s3 per rpt-74091 "bridging pfizer hal severity ranking to severity numbers applied in the thermacare heat wrap rmp", version 1.0, effective date: 28sep2018.Safety is notified of s3, s4 and s5 per sop-58303 "processing consumer complaints", section 7.4, version 10.0, effective date: 15nov2018.Date of capa implementation:process related? no complaint confirmed?: no.Design related: no notify safety: no.Follow-up (18feb2019): new information received from the product quality complaint group included investigational results.Follow-up (22feb2019): new information received from the product quality complaint group included investigational results.Company clinical evaluation comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.The above referenced lot number: s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time., comment: the patient reported that one of the heat pockets had ruptured and she had black powder running down her leg.No adverse event was associated with the use of the device.This single event malfunction has a theoretical risk to cause skin burn.Additional follow-up will be reported as it becomes available.The above referenced lot number: s68516 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots [s68516, t26686, t26691, t26693, 8054ha, 8054hb] due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.The review of the lot/batch records does not suggest a defect or quality issue related to the manufacture of this lot.No device malfunction has been identified.No remedial action/corrective action/field safety corrective action is suggested at this time.
|
| |
|
Search Alerts/Recalls
|
|
|
