MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-22 for 90098843 MATERNITY PAD 2022A manufactured by Covidien.
[43474070]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[43474071]
It was reported to covidien on 4/18/2016 that the customer had an issue with a maternity pad. The customer states that the adhesive of the pad was unusually strong. Her leg was exposed to the adhesive which lead to her being hospitalized and treated with iv antibiotics for a skin infection.
Patient Sequence No: 1, Text Type: D, B5
[45761584]
One returned sample was received from the customer. The sample was sent to the supplier for investigation. Testing was performed on the pad for microbiological and for adhesion. All tests passed and were within specification. A review of the device history record was not performed during this investigation as the lot number was not received with the complaint. All device history records are reviewed and approved by quality prior to release of product. Because there was no lot number, a date of manufacture could not be determined. This complaint will be considered unconfirmed. A root cause could not be identified. A possible root cause could be sensitivity to the adhesive directly on the skin or the fragile area the adhesive from the pad had shifted to. As this complaint will be unconfirmed, no corrective action is planned at this time. If additional information is received, the investigation will resume as needed. This complaint will be used for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00134 |
| MDR Report Key | 5599759 |
| Date Received | 2016-04-22 |
| Date of Report | 2016-04-18 |
| Date Mfgr Received | 2016-05-23 |
| Date Added to Maude | 2016-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90098843 MATERNITY PAD |
| Generic Name | MATERNITY PAD |
| Product Code | HIL |
| Date Received | 2016-04-22 |
| Model Number | 2022A |
| Catalog Number | 2022A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-22 |