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The root cause category is non assignable (complaint not confirmed).The root cause of why the wrap did not adhere to consumers' clothing then causing red marks is inconclusive since review of records does not provide evidence to support defective product.The sample is not available for evaluation by the site, it cannot be confirmed if there was any issues with the adhesive applied to the smms material that prevented the wrap from sticking.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.The product quality for the batch is not impacted by this complaint.Investigation pr # menstrual & muscle joint us cells damaged/leaking was conducted for the subclass.Of cell pack damage/leaking.This batch t26691 was reviewed at aqrt and the outcome was to recall the four batches # per investigation pr#.This complaint does not mention cells damaged or leaking.For batch w87447, same results as above with this addition: this is a potential device malfunction s2-user skin reaction- per rpt-# bridging pfizer hal severity numbers applied in the thermacare heatwrap rmp, effective 28sep2018, version 1.0.A site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.Product quality complaints provided a severity of harm rating of s3.The patient no longer has the product.
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Red mark/she always get redness where she puts it, because it's hot [erythema], because it's hot [device issue], did not stick [device adhesion issue].Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (thermacare menstrual) lot number t26691; w87447; w3362, udi number: (b)(4), from unknown date for unknown indication.Medical history and concomitant medications were not reported.Consumer had 4 boxes of the thermacare menstrual heatwraps and they were recalled.She used one and it did not stick and left a red mark that lasted 2 days.Consumer used the thermacare menstrual heat wraps, the eight hour ones, and she read that there was a recall, and she had four boxes at home.She bought them last month, and used two out of three from the first box.She always got redness where she put it, because it's hot, but she's not had a reaction or anything.The action taken in response to the event of the product was unknown.The event outcome was resolved.According to investigations results from product quality complaints (pqc) group, lot number w3362 invalid.Initial complaint assessment: 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: 01jan2016 through 31jan2019/ manufacturing site: pfizer (b)(4)/complaint class: external cause investigation/ complaint sub class: adverse event safety request for investigation.The pcom search returned a total of 70 complaints for menstrual products during this time period for the class/subclass.Of the 70 complaints; 16 complaints has the batch number recorded as "unknown".The 54 remaining complaints were evaluated.There was one complaint confirmed to have a manufacturing process root cause for the complaint of adverse event.The root cause was identified as equipment - other.Investigation pr (b)(4) for t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking was conducted for the subclass of cell pack damage/leaking.The confirmed adverse event involved one of these batches and was caused by a leaking cell pack.These batches were reviewed at aqrt and the outcome was to recall the four batches (t26691, t26693, and t26686 & s68516).This current complaint does not mention cells damage/leaking.Based on this pcom search for the subclass of adverse event safety request investigation for menstrual products, the data did not show an increase over time (36 months).There is not a trend identified for the subclass adverse event for menstrual products, refer to attachment menstrual trending graph.Investigation summary: the root cause category is non assignable (complaint not confirmed).The root cause of why the wrap did not adhere to consumers' clothing then causing red marks is inconclusive since review of records does not provide evidence to support defective product.The sample is not available for evaluation by the site, it cannot be confirmed if there was any issues with the adhesive applied to the smms material that prevented the wrap from sticking.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.The product quality for the batch is not impacted by this complaint.Investigation pr # menstrual & muscle joint us cells damaged/leaking was conducted for the subclass.Of cell pack damage/leaking.This batch t26691 was reviewed at aqrt and the outcome was to recall the four batches # per investigation pr#.This complaint does not mention cells damaged or leaking.For batch w87447, same results as above with this addition: a site investigation was conducted on production records, a return sample was not received.A device malfunction was not identified during records review.During follow-up on 24oct2019, product quality complaints provided a severity of harm rating of s3.The patient no longer has the product.No follow-up attempts are possible.No further information is expected.Follow-up (04jan2019): new information received from a contactable consumer included: udi number, event details and new product complaint term (because it's hot).Follow-up (25feb2019): new information received from product quality complaints (pqc) group includes investigations results.Follow-up (15mar2019): new information received from product quality complaints (pqc) group includes investigations results.Follow-up (30apr2019): follow-up attempts are completed.No further information is expected.Follow-up (01may 2019): new information reported from product quality complaints includes product investigation results for lot number w87447.Follow-up attempts are completed.No further information is expected.Follow-up (24oct2019): new information from product quality complaints includes: updated severity of harm rating (s3) and device availability (patient no longer has the product).This follow-up upgrades the case to a serious, reportable malfunction mdr.Company clinical evaluation comment: based on the information provided, the events erythema, device issue and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.Comment: based on the information provided, the events erythema, device issue and device adhesion issue as described are considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure.The events are medically assessed as associated with the use of the device.
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