|
|
| Lot Number AW2098 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Skin Irritation (2076); Fluid Discharge (2686); Blister (4537)
|
| Event Date 11/02/2020 |
|
Event Type
Injury
|
|
Event Description
|
|
Blisters/one of the blisters is oozing [blister], blisters/one of the blisters is oozing [blister rupture], redness/ the redness has continued [erythema].Narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) via an unspecified route of administration from an unspecified date to help alleviate her menstrual cramps.The patient's medical history and concomitant medications were not reported.The patient stated she had used the thermacare menstrual heat wraps for years to help alleviate her menstrual cramps.Yesterday on (b)(6) 2020 when wearing one, everything seemed fine, however when she went to take it off, (after approximately 6-7 hours of wear time) she had blisters and redness.On (b)(6) 2020 one of the blisters was oozing and the redness had continued.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.
|
| |
|
Event Description
|
|
Event verbatim [preferred term].Blisters/one of the blisters is oozing [blister], blisters/one of the blisters is oozing [blister rupture], redness/ the redness has continued [erythema], , narrative: this is a spontaneous report from a contactable consumer.A female patient of an unspecified age started to receive thermacare heatwrap (thermacare menstrual) from an unspecified date to help alleviate her menstrual cramps.The patient's medical history and concomitant medications were not reported.The patient stated she had used thermacare menstrual heatwraps for years to help alleviate her menstrual cramps.Yesterday on (b)(6) 2020 when wearing one, everything seemed fine, however when she went to take it off, (after approximately 6-7 hours of wear time) she had blisters and redness.On (b)(6) 2020 one of the blisters was oozing and the redness had continued.The consumer provided a photo of the product packaging that included device lot # aw2098 n 05/15, expiration date apr2022 consumer is not sure when or where she purchased the heatwrap.The action taken in response to the events for thermacare heatwrap was unknown.The outcome of the events was not resolved.Additional information has been requested and will be provided as it becomes available.Follow-up (04nov2020): new information received from the product quality complaints group included: photo of product packaging, lot # aw2098 n 05/15, expiration date apr2022.
|
| |
|
Manufacturer Narrative
|
|
Batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused, " yesterday when wearing one, everything seemed fine, however when i went to take it off, (after approximately 6-7 hours of wear time) i had blisters and redness.Today one of the blisters is oozing and the redness has continued", is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this (company name) search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment menstrual 8hr products adverse event serious unknown (b)(6)2017 to (b)(6)2020.Site sample status was received at the site on 09nov2020.Return sample evaluation: one menstrual carton, carton is open.One menstrual pouch, pouch is sealed; no obvious defects.One menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.No obvious defects to wrap.Process related was no.Final confirmation status was not confirmed.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] blisters/one of the blisters is oozing [blister], blisters/one of the blisters is oozing/larger blister was seeping for a bit [blister rupture], redness/ the redness has continued [erythema], broken skin [skin disorder].Narrative: this is a spontaneous report from a contactable healthcare professional (patient).A 38-year-old female (non-pregnant) patient started to receive thermacare heatwrap (thermacare menstrual) lot number aw2098, expiration date apr2022, on (b)(6)2020 at 1 wrap per month to help alleviate her menstrual cramps.Medical history included sensitive skin, asthma, attention deficit disorder (add) and have taken add medication for approximately 10-12 years without issues.Concomitant medication included addison 10 mg used 4 doses daily for attention deficit disorder.The patient stated she had used thermacare menstrual heatwraps for years to help alleviate her menstrual cramps without issues.Yesterday on (b)(6)2020 when wearing one, everything seemed fine, however when she went to take it off, (after approximately 6-7 hours of wear time) she had blisters and redness.On (b)(6)2020 one of the blisters was oozing and the redness had continued.The consumer provided a photo of the product packaging that included device lot # aw2098 n 05/15, expiration date apr2022.Consumer is not sure when or where she purchased the heatwrap.As of (b)(6)2020, it was reported that the patient classified her skin tone as medium.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box of thermacare menstrual.The product was remaining.The product was used 1 day in a row, and 6-7 hours per day.She had previously used thermacare for many year without issues (monthly for years, for 6-8 hours).She had not previously used other heat products for pain relief.The patient attached the adhesive to clothing.She placed the adhesive side to her underwire during work, wore it for 6-7 hours.She did not engage in exercise while using the product.She checked her skin under the product while wearing thermacare, approximately nearly 2-3 when using restroom.She read the usage instructions on thermacare before used the product.She didn't feel the product got too hot but blister appeared the last 2-3 hours.She noticed blister on her lower abdominal area taking the product off.That wrap helping relieve menstrual cramps.She didn't notice anything until she went to take the warp off, when she noticed the blister that was open and was intact.The blister lasted 5 day to current.Redness experienced was typical after applying heat.She had 2 blisters and a small area of broken skin in (b)(6)2020.The broken skin and the small blister had completely healed.The larger blister is almost healed not completely.She was check for infection as the larger blister was seeping for a bit.Treatment received for blisters/one of the blisters is oozing included bandage and use burn cream pen.No treatment received for redness.She was not admitted to hospital due to blister/blister oozing and redness.The action taken in response to the events for thermacare heatwrap was permanently discontinued on (b)(6)2020.The outcome of "redness/ the redness has continued and broken skin" was resolved in (b)(6)2020.The outcome of "blisters/one of the blisters is oozing/larger blister was seeping for a bit" was resolving.According to product quality complaint: summary of investigation: date of manufacture: 09may2019 to 22may2019.Batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused, " yesterday when wearing one, everything seemed fine, however when i went to take it off, (after approximately 6-7 hours of wear time) i had blisters and redness.Today one of the blisters is oozing and the redness has continued", is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this (company name) search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment menstrual 8hr products adverse event serious unknown (b)(6)2020.Site sample status was received at the site on 09nov2020.Return sample evaluation: one menstrual carton, carton is open.One menstrual pouch, pouch is sealed; no obvious defects.One menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.No obvious defects to wrap.Process related was no.Final confirmation status was not confirmed.Follow-up (04nov2020): new information received from the product quality complaints group included: photo of product packaging, lot # aw2098 n 05/15, expiration date apr2022.Follow-up (19nov2020): new information received from a contactable other hcp included: reporter occupation, patient data (age), suspect product data (start/stop date, dosage, action taken), medical history, concomitant medication, past product history, event details, new event (broken skin), treatment received, lab data, events outcome.Follow-up (27nov2020): follow-up attempts completed.No further information expected.Follow-up (01dec2020): new information received from product quality complaint includes investigation results.Follow-up attempts are completed.No further information is expected.
|
| |
|
Event Description
|
|
Event verbatim [preferred term].Blisters/one of the blisters is oozing [blister], blisters/one of the blisters is oozing/larger blister was seeping for a bit [blister rupture], redness/ the redness has continued [erythema], broken skin [skin disorder], narrative: this is a spontaneous report from a contactable healthcare professional (patient).A 38-year-old female (non-pregnant) patient started to receive thermacare heatwrap (thermacare menstrual) lot number aw2098, expiration date apr2022, on (b)(6) 2020 at 1 wrap per month to help alleviate her menstrual cramps.Medical history included sensitive skin, asthma, attention deficit disorder (add) and have taken add medication for approximately 10-12 years without issues.Concomitant medication included addison 10 mg used 4 doses daily for attention deficit disorder.The patient stated she had used thermacare menstrual heatwraps for years to help alleviate her menstrual cramps without issues.Yesterday on (b)(6) 2020 when wearing one, everything seemed fine, however when she went to take it off, (after approximately 6-7 hours of wear time) she had blisters and redness.On (b)(6) 2020 one of the blisters was oozing and the redness had continued.The consumer provided a photo of the product packaging that included device lot # aw2098 n 05/15, expiration date apr2022.Consumer is not sure when or where she purchased the heatwrap.As of (b)(6) 2020, it was reported that the patient classified her skin tone as medium.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box of thermacare menstrual.The product was remaining.The product was used 1 day in a row, and 6-7 hours per day.She had previously used thermacare for many year without issues (monthly for years, for 6-8 hours).She had not previously used other heat products for pain relief.The patient attached the adhesive to clothing.She placed the adhesive side to her underwire during work, wore it for 6-7 hours.She did not engage in exercise while using the product.She checked her skin under the product while wearing thermacare, approximately nearly 2-3 when using restroom.She read the usage instructions on thermacare before used the product.She didn't feel the product got too hot but blister appeared the last 2-3 hours.She noticed blister on her lower abdominal area taking the product off.That wrap helping relieve menstrual cramps.She didn't notice anything until she went to take the warp off, when she noticed the blister that was open and was intact.The blister lasted 5 day to current.Redness experienced was typical after applying heat.She had 2 blisters and a small area of broken skin in (b)(6) 2020.The broken skin and the small blister had completely healed.The larger blister is almost healed not completely.She was check for infection as the larger blister was seeping for a bit.Treatment received for blisters/one of the blisters is oozing included bandage and use burn cream pen.No treatment received for redness.She was not admitted to hospital due to blister/blister oozing and redness.The action taken in response to the events for thermacare heatwrap was permanently discontinued on 02nov2020.The outcome of "redness/ the redness has continued and broken skin" was resolved in (b)(6) 2020.The outcome of "blisters/one of the blisters is oozing/larger blister was seeping for a bit" was resolving.Additional information has been requested and will be provided as it becomes available.Follow-up (on (b)(6) 2020): new information received from the product quality complaints group included: photo of product packaging, lot # aw2098 n 05/15, expiration date apr2022.Follow-up (on (b)(6) 2020): new information received from a contactable other hcp included: reporter occupation, patient data (age), suspect product data (start/stop date, dosage, action taken), medical history, concomitant medication, past product history, event details, new event (broken skin), treatment received, lab data, events outcome.
|
| |
|
Manufacturer Narrative
|
|
Batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused, "yesterday when wearing one, everything seemed fine, however when i went to take it off, (after approximately 6-7 hours of wear time) i had blisters and redness.Today one of the blisters is oozing and the redness has continued", is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this (company name) search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment menstrual 8hr products adverse event serious unknown 03nov2017 to 03nov2020.Site sample status was received at the site on 09nov2020.Return sample evaluation: one menstrual carton, carton is open.One menstrual pouch, pouch is sealed; no obvious defects.One menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.No obvious defects to wrap.Process related was no.Final confirmation status was not confirmed.
|
| |
|
Event Description
|
|
Event verbatim [preferred term] blisters/one of the blisters is oozing [blister], blisters/one of the blisters is oozing/larger blister was seeping for a bit [blister rupture], redness/ the redness has continued [erythema], broken skin [skin disorder], , narrative: this is a spontaneous report from a contactable healthcare professional (patient).A 38-year-old female (non-pregnant) patient started to receive thermacare heatwrap (thermacare menstrual) lot number aw2098, expiration date apr2022, on (b)(6)2020 at 1 wrap per month to help alleviate her menstrual cramps.Medical history included sensitive skin, asthma, attention deficit disorder (add) and have taken add medication for approximately 10-12 years without issues.Concomitant medication included addison 10 mg used 4 doses daily for attention deficit disorder.The patient stated she had used thermacare menstrual heatwraps for years to help alleviate her menstrual cramps without issues.Yesterday on (b)(6) 2020 when wearing one, everything seemed fine, however when she went to take it off, (after approximately 6-7 hours of wear time) she had blisters and redness.On (b)(6) 2020 one of the blisters was oozing and the redness had continued.The consumer provided a photo of the product packaging that included device lot # aw2098 n (b)(6), expiration date (b)(6) 2022.Consumer is not sure when or where she purchased the heatwrap.As of (b)(6) 2020, it was reported that the patient classified her skin tone as medium.She had sensitive skin.She did not have any abnormal skin conditions.She purchased red box of thermacare menstrual.The product was remaining.The product was used 1 day in a row, and 6-7 hours per day.She had previously used thermacare for many year without issues (monthly for years, for 6-8 hours).She had not previously used other heat products for pain relief.The patient attached the adhesive to clothing.She placed the adhesive side to her underwire during work, wore it for 6-7 hours.She did not engage in exercise while using the product.She checked her skin under the product while wearing thermacare, approximately nearly 2-3 when using restroom.She read the usage instructions on thermacare before used the product.She didn't feel the product got too hot but blister appeared the last 2-3 hours.She noticed blister on her lower abdominal area taking the product off.That wrap helping relieve menstrual cramps.She didn't notice anything until she went to take the warp off, when she noticed the blister that was open and was intact.The blister lasted 5 day to current.Redness experienced was typical after applying heat.She had 2 blisters and a small area of broken skin in (b)(6) 2020.The broken skin and the small blister had completely healed.The larger blister is almost healed not completely.She was check for infection as the larger blister was seeping for a bit.Treatment received for blisters/one of the blisters is oozing included bandage and use burn cream pen.No treatment received for redness.She was not admitted to hospital due to blister/blister oozing and redness.The action taken in response to the events for thermacare heatwrap was permanently discontinued on (b)(6) 2020.The outcome of "redness/ the redness has continued and broken skin" was resolved in (b)(6) 2020.The outcome of "blisters/one of the blisters is oozing/larger blister was seeping for a bit" was resolving.According to product quality complaint: summary of investigation: date of manufacture: 09may2019 to 22may2019.Batch aw2098 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Conclusion: the root cause category is non assignable (complaint not confirmed as a quality defect).After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports the wrap caused, " yesterday when wearing one, everything seemed fine, however when i went to take it off, (after approximately 6-7 hours of wear time) i had blisters and redness.Today one of the blisters is oozing and the redness has continued", is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.The plant has reviewed this batch from a manufacturing perspective.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.The product quality for the batch is not impacted by this complaint.Lot trend assmt.& rationale: an evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event/serious/unknown received at the albany site requiring an evaluation for this batch.On the basis of this evaluation, a trend does not exist for this lot.Exped trend assmt.& rationale: an evaluation was made by searching for possible trend for this subclass.Based on this (company name) search, a trend does not exist for the subclass of adverse event/serious/unknown for menstrual 8hr products the data did not show an increase over time (36 months).There is not a trend identified for the subclass of adverse event/serious/unknown for menstrual 8hr products, refer to attachment menstrual 8hr products adverse event serious unknown 03nov2017 to 03nov2020.Site sample status was received at the site on 09nov2020.Return sample evaluation: one menstrual carton, carton is open.One menstrual pouch, pouch is sealed; no obvious defects.One menstrual wrap - wrap is inside sealed pouch; opened pouch to inspect wrap.No obvious defects to wrap.Process related was no.Final confirmation status was not confirmed.According to device complaint handling unit (dchu), severity of harm was assessed as s3.Reasonably suggested malfunction was yes.Follow-up (04nov2020): new information received from the product quality complaints group included: photo of product packaging, lot # aw2098 n 05/15, expiration date apr2022.Follow-up (19nov2020): new information received from a contactable other hcp included: reporter occupation, patient data (age), suspect product data (start/stop date, dosage, action taken), medical history, concomitant medication, past product history, event details, new event (broken skin), treatment received, lab data, events outcome.Follow-up (27nov2020): follow-up attempts completed.No further information expected.Follow-up (01dec2020): new information received from product quality complaint includes investigation results.Follow-up attempts are completed.No further information is expected.Follow-up (19jan2021): new information received from device complaint handling unit (dchu) included: severity of harm was assessed as s3.Follow-up attempts are completed.No further information is expected.
|
| |
|
Search Alerts/Recalls
|
|
|
